MAUDE Adverse Event Report: CODMAN AND SHUNTLEFF, INC. VP CODMAN CERTAS BRAIN SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number NOT GIVEN

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Disability (2371)

Event Date 08/07/2018

Event Type  Injury  

Event Description

(b)(6) put a codman certas vp shunt in.Completely malfunctioned causing my daughter to have severe disabilities.She went from a small brain injury to almost death.Please recall these asap.Codman certas vp shunts lead to death.Fda safety report id# (b)(4).

• Brand Name: VP CODMAN CERTAS BRAIN SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): CODMAN AND SHUNTLEFF, INC.
• MDR Report Key: 8500563
• MDR Text Key: 141661555
• Report Number: MW5085737
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NOT GIVEN
• Device Catalogue Number: NOT GIVEN
• Device Lot Number: NOT GIVEN
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 19 YR